Clinical Trial Specialist

2 days ago

Ridgefield, Connecticut, United States McInnis Inc. Full time
Job Description

Job Summary

We are seeking a highly motivated and experienced Clinical Trial Specialist to join our team at McInnis Inc. The successful candidate will be responsible for managing clinical trials from start to finish, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities

  • Manage clinical trials from start to finish, including site selection, patient recruitment, and data management.
  • Ensure compliance with regulatory requirements and industry standards, including ICH, GCPs, and FDA guidelines.
  • Develop and implement trial protocols, including study designs, sampling plans, and data collection methods.
  • Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and data management.
  • Provide training and support to site staff, investigators, and other stakeholders.
  • Monitor and report on trial progress, including site performance, patient recruitment, and data quality.
  • Identify and mitigate risks, including adverse events, protocol deviations, and data discrepancies.
  • Develop and implement corrective actions to address trial issues and ensure compliance with regulatory requirements.

Requirements

  • Four (4) year degree, preferably in life sciences, or an RN with relevant clinical trial experience.
  • Five (5) years of experience in clinical trials, preferably in oncology or in-house monitoring.
  • Excellent communication and project management skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
  • Proficiency in computer skills, including CTMS, SharePoint, and Microsoft Office.

Desired Experience, Skills and Abilities

  • Experience with clinical trial management systems, including CTMS and EDC.
  • Knowledge of regulatory requirements, including ICH, GCPs, and FDA guidelines.
  • Experience with data management, including data cleaning, data analysis, and data reporting.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Strong attention to detail and organizational skills.
  • Ability to communicate effectively with stakeholders, including site staff, investigators, and sponsors.

Work Environment

  • Remote work arrangement available.
  • 8-hour shift, Monday to Friday.
  • Salary: $50.00 - $54.00 per hour.

How to Apply

Interested candidates should submit their resume and cover letter to [insert contact information].

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